Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-01-13 @ 4:07 PM
Study NCT ID:
NCT07238712
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D054438', 'term': 'Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'D000069594', 'term': 'Abatacept'}], 'ancestors': [{'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival analysis', 'timeFrame': '2 years', 'description': 'Measure: Kaplan-Meier estimate of death from all causes'}], 'secondaryOutcomes': [{'measure': 'Incidence of secondary hemophagocytic lymphohistiocytosis', 'timeFrame': '100 days', 'description': 'Based on H-score diagnostic criteria.'}, {'measure': 'Incidence of HSCT-associated adverse events (safety and toxicity)', 'timeFrame': '100 days', 'description': 'Toxicity assessment is based on NCI CTC AE 6.0 grades. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2016. Transplant-associated microangiopathy incidence assessment is based on Schoettler et al. criteria. All toxicity measurements will be aggregated as severity scores.'}, {'measure': 'Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence', 'timeFrame': '100 days', 'description': 'Proportion of patients, requiring systemic treatment for bacterial, viral and fungal disease'}, {'measure': 'Incidence of acute GVHD grade II-IV', 'timeFrame': '180 days', 'description': 'Cumulative incidence of patients with acute GVHD II-IV grade'}, {'measure': 'Incidence of moderate and severe chronic GVHD', 'timeFrame': '2 years', 'description': 'Cumulative incidence of patients with moderate and severe chronic GVHD according to MAGIC 2018 criteria'}, {'measure': 'Non-relapse mortality analysis', 'timeFrame': '2 years', 'description': 'Cumulative incidence of patients with mortality without hematological relapse of malignancy'}, {'measure': 'Relapse rate analysis', 'timeFrame': '2 years', 'description': 'Cumulative incidence of patients with relapse'}, {'measure': 'Event-free survival analysis', 'timeFrame': '2 years', 'description': 'Kaplan-Meier estimate of death or relapse'}, {'measure': 'GVHD-event-free survival analysis', 'timeFrame': '2 years', 'description': 'Kaplan-Meier estimate of death, grade III-IV acute GVHD, severe chronic GVHD or relapse'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-transplantation cyclophosphamide', 'Post-transplantation bendamustine', 'graft-versus-host disease', 'abatacept', 'ruxolitinib'], 'conditions': ['Acute Myeloid Leukemia (AML)', 'Chronic Myeloid Leukemia', 'Myelodysplastic Syndromes (MDS)', 'Myeloprolipherative Neoplsm', 'Atypical Chronic Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '40372957', 'type': 'BACKGROUND', 'citation': 'Moiseev I, Bondarenko S, Vlasova Y, Morozova E, Smirnova A, Epifanovskaya O, Zhogolev D, Chernishova D, Meliboev A, Khudayberdiev J, Mazing A, Lapin S, Kholopova I, Botina A, Baykov V, Popova M, Kosarev O, Kulagin A. Allogeneic hematopoietic cell transplantation with a combination of posttransplantation bendamustine and cyclophosphamide in refractory myeloid neoplasms. Cancer. 2025 May 15;131(10):e35893. doi: 10.1002/cncr.35893.'}]}, 'descriptionModule': {'briefSummary': 'Optimization of bendamustine-containg graft-versus-host disease (GVHD) prophylaxis to reduce the incidence of secondary haemophagocytic lymphohistiocytosis and GVHD', 'detailedDescription': 'Prognosis of patients undergoing allogeneic stem cell transplantation (HCT) for high-risk myeloid malignancies, including refractory acute myeloid leukemia, with standard HCT technologies have relatively poor prognosis with 10-30% long-term disease-free survival. One of the approaches to augment graft-versus-leukemia effect the use of post-transplantation bendamustine in graft-versus-host disease prophylaxis. Despite high frequency of responses and durable remissions after this approach majority of patients develop a serious complication - cytokine release syndrome, which can be life-threatening in some patients. The combination bendamustine (PTB) and post-transplantation cyclophosphamide (PTCY) facilitates comparable graft-versus leukemia effect to PTB, but with better safety profile and reduced incidence of severe cytokine release syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\<10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness\n\nExclusion Criteria:\n\n* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with \\<10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms - High-risk disease defined as: Acute myeloid leukemia: \\>5% of clonal blasts in bone marrow despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: \\>5% of blasts despite previous therapy Myeloid malignancy with with -7 or complex karyotype, or p53 mutation regardless of blast count in bone marrow Treatment-related myelodysplastic syndrome Second or subsequent allogeneic HCT after relapse of a myeloid malignancy Chronic myelomonocytic leukemia Myeloprolipherative neoplasms, unclassifiable\n\n\\- No severe concurrent illness'}, 'identificationModule': {'nctId': 'NCT07238712', 'acronym': 'APTBCy', 'briefTitle': 'Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor', 'organization': {'class': 'OTHER', 'fullName': 'St. Petersburg State Pavlov Medical University'}, 'officialTitle': 'Optimization of Post-transplantation Benadamustine and Cyclophosphamide in Patients With High-risk Myeloid Malignancies and a Partially Mismatched Donor (APTBCy)', 'orgStudyIdInfo': {'id': '30/25-n'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Test cohort 1 - ruxolitinib', 'description': 'Days +3 through +4: Bendamustine 50 mg/m2 iv x 2 days; Days +3 through +4: Cyclophosphamide 25 mg/kg iv x 2 days; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.; mycophenolate mofetil Days +5 through +35 30 mg/kg/day p.o.; Days +5 through +100: Tacrolimus 0.03 mg/kg/day with further correction by concentration', 'interventionNames': ['Drug: Ruxolitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Test cohort 2 - abatacept', 'description': 'Days +3 through +4: Bendamustine 50 mg/m2 iv x 2 days; Days +3 through +4: Cyclophosphamide 25 mg/kg iv x 2 days; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.; mycophenolate mofetil Days +5 through +35 30 mg/kg/day p.o.; Days +5 through +100: Tacrolimus 0.03 mg/kg/day with further correction by concentration', 'interventionNames': ['Drug: Abatacept (Orencia)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Expansion cohort', 'description': 'Days +3 through +4: Bendamustine 50 mg/m2 iv x 2 days; Days +3 through +4: Cyclophosphamide 25 mg/kg iv x 2 days; Days -1,+5, +14, +21 abatacept 10 mg/kg/day i.v.; Days +5 through +100: Tacrolimus 0.03 mg/kg/day with further correction by concentration', 'interventionNames': ['Drug: Abatacept (Orencia)']}], 'interventions': [{'name': 'Ruxolitinib', 'type': 'DRUG', 'description': '; Days -1 through +21: ruxolitinib 10 mg/kg/day p.o.', 'armGroupLabels': ['Experimental: Test cohort 1 - ruxolitinib']}, {'name': 'Abatacept (Orencia)', 'type': 'DRUG', 'description': 'Days -1,+5, +14, +21 abatacept 10 mg/kg/day i.v.', 'armGroupLabels': ['Experimental: Expansion cohort', 'Test cohort 2 - abatacept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '197022', 'city': 'Saint Petersburg', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'role': 'CONTACT', 'email': 'moisiv@mail.ru', 'phone': '8123387193'}], 'facility': 'Pavlov University', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'centralContacts': [{'name': 'Alexandr D Kulagin, MD, Prof', 'role': 'CONTACT', 'email': 'bmt-director@1spbgmu.ru', 'phone': '+78123386265'}, {'name': 'Ivan S Moiseev, MD, Prof.', 'role': 'CONTACT', 'email': 'moisiv@mail.ru', 'phone': '+78123386201'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '10 years', 'ipdSharing': 'YES', 'accessCriteria': 'Submit a study proposal and request to use the data to Pavlov University Clinical Trial department: spbgmutrials@yandex.ru'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Petersburg State Pavlov Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RM Gorbacheva Research Institute Scientific director', 'investigatorFullName': 'Ivan S Moiseev', 'investigatorAffiliation': 'St. Petersburg State Pavlov Medical University'}}}}